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FDA Approval

KINKAN

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
KINKANDO CO., LTD .
DUNS: 694329470
Effective Date
June 10, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Ammonia(1.1 g in 50 mL)
Camphor(1.55 g in 50 mL)
Menthol(3 g in 50 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

KINKANDO CO., LTD .

KINKANDO CO., LTD .

715451980

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

KINKAN

Product Details

NDC Product Code
51027-0007
Application Number
M017
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
June 10, 2025
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
AmmoniaActive
Code: 5138Q19F1XClass: ACTIBQuantity: 1.1 g in 50 mL
CamphorActive
Code: N20HL7Q941Class: ACTIBQuantity: 1.55 g in 50 mL
MentholActive
Code: L7T10EIP3AClass: ACTIBQuantity: 3 g in 50 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - 50 mL Bottle Label

NDC 51027-0007-1

KINKAN

PAIN
RELIEVING
LINIMENT

MANUFACTURED BY
**KINKANDO CO., LTD.**350-2 KODAMACHOKYOEI,
HONJO-SHI, SAITAMA 367-0206,
JAPAN

DISTRIBUTED BY
PMAI21112 Figueroa Street unit B

Carson, CA 90745

1.7 FL OZ (50mL)

Principal Display Panel - 50 mL Bottle Label


INDICATIONS & USAGE SECTION

Uses

Temporary relief of minor aches and pains of muscles and joints due to

  • simple backache
  • arthritic
  • strains
  • bruises
  • sprains

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 6 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 6 years of age: Do not use, consult a doctor.


WARNINGS SECTION

Warnings

For external use only

Flammable keep away from fire or flame

Do not use on

  • wounds
  • damaged skin

When using this product

  • avoid contact with the eyes and mouth
  • do not bandage tightly

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact.“a Poison Control Center right away.”


OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Ammonia 2.3%

Camphor 3.1%

Menthol 6.0%

OTC - PURPOSE SECTION

Purpose

External Analgesic

External Analgesic

External Analgesic

OTC - QUESTIONS SECTION

Questions and comments

Call 1-310-661-7260 Mon.-Fri. (2p.m. - 3p.m. PST)


SPL UNCLASSIFIED SECTION

Drug Facts

OTHER SAFETY INFORMATION

Other Information

  • Store at room temperature under 86°F (30°C)
  • Flammable. keep away from fire or flame

INACTIVE INGREDIENT SECTION

Inactive ingredients

Geraniol-denatured Alcohol


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